510(k) Report

Devices descending from K941797

8 later devices reach Immulite SHBG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083867Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin…Beckman Coulter, Inc.200921
+1K031717Elecsys SHBG ImmunoassayRoche Diagnostics Corp.20034—
+2K233480Access SHBGBeckman Coulter, Inc.20240—
+2K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc.201902
+2K102814Elecysys SHBGRoche Diagnostics20110—
+2K060818Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control…Biokit, S.A.200721
+3K152185Architect SHBGBiokit, S.A.20160—
+3K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetTosoh Bioscience, Inc.201501